LETTER
On behalf of the Microbiology Committee of the College of American Pathologists (CAP), we respond to the recent commentary by Kirby and colleagues on the topic of bringing in new antimicrobial susceptibility testing (1). The authors state that “there is a lack of clarity regarding verification requirements for bringing in testing for each new antibiotic using platforms and methods that are already established in the clinical laboratory” and argue that quality control can be used in place of conventional verification studies (i.e., verification of accuracy and precision). While we appreciate the intent behind the authors’ arguments, we wish to point out that the State Operations Manual of the Centers for Medicare and Medicaid Services (CMS) (2) clearly defines the requirements for verification of performance specifications for all nonwaived test systems implemented in the laboratory on or after 24 April 2003. According to this document (2), laboratories are required to verify performance specifications for “an analyte added to a test system that can measure multiple analytes which the laboratory has been using for patient testing but has not previously reported patient results for this particular analyte.” According to the standard in §493.1253 of the Electronic Code of Federal Regulations (3), verification studies must include an assessment of accuracy, precision, and reportable ranges for test results. Laboratories must also verify that the reference intervals provided by the manufacturer are appropriate for the patient population that the laboratory serves.
The CAP has deemed status as an accrediting organization for clinical laboratories under the Clinical Laboratory Improvement Amendments (CLIA) and must act in accordance with federal law. Thus, the CAP and other agencies with deemed status must require laboratories to carry out appropriate verification studies in accordance with CLIA. While all of the components listed above must be included in these studies, the type and extent of studies are at the discretion of the laboratory director. The Clinical and Laboratory Standards Institute (CLSI) provides clear guidance for performing these verification studies and serves as a valuable reference for laboratories wishing to implement new antimicrobial susceptibility testing (4).
ACKNOWLEDGMENTS
This letter was submitted with approval from the College of American Pathologists.
Dr. Romney M. Humphries is employed by Accelerate Diagnostics, Inc., and owns stocks in the company. Dr. Richard B. Thomson serves as a consultant for Accelerate Diagnostics, Inc., and is the Chair of the Microbiology Expert Panel for the CLSI. Dr. Dan D. Rhoads receives research funding for work on novel antibacterial agents through Shionogi Inc., Tetraphase Pharmaceuticals Inc., and Venatorx Pharmaceuticals. The other authors have no relevant conflicts of interest.
FOOTNOTES
For the author reply, see https://doi.org/10.1128/JCM.02062-19.
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